Colonoscopy PreparationPhase 2NCT01887470
2 Regimens of Lactulose for Colonoscopy Preparation in Adults
A Phase 2 study testing Full dose preparation and Split dose preparation in people with Colonoscopy Preparation, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- Full dose preparation and Split dose preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring bowel evacuation for colonoscopy.
Who cannot join
- Patients with galactosemia (galactose-sensitive diet).
- Patients known to be hypersensitive to any of the components of lactulose for oral solution.
- Patients with an abnormality on screening blood work or vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts.
- Patients with a history of impaired renal function.
- Patients with current or recent history of hypotension, as defined by the Investigator.
- Patients with a history of long Q-T syndrome.
Show all 15Show fewer
- Patients with a history of a failed bowel preparation.
- Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives.
- Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery.
- Patients on lactulose therapy or receiving any treatment for chronic constipation.
- Be pregnant or nursing.
- Patients with known large polyps or flat polyps (i.e. polyps requiring electrocautery or argon plasma coagulation).
- Patients less than 18 years of age.
- Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of 2 Regimens of Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.
Read the detailed description
A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose regimen, where three doses are taken on the prior evening, and one dose is taken the morning of the procedure.
- Conditions
- Colonoscopy Preparation
- Being tested
- Full dose preparation, Split dose preparation
- Keywords
- Bowel Evacuation, Colonoscopy Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full dose preparationDrug
Also called Evening-only Regimen
Split dose preparationDrug
| Study group | Role | What they receive |
|---|---|---|
| Full dose preparation; AM colonoscopy | Experimental | Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day. Receives: Drug: Full dose preparation |
| Full dose preparation; PM colonoscopy | Experimental | Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day. Receives: Drug: Full dose preparation |
| Split dose preparation; AM colonoscopy | Experimental | Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon. Receives: Drug: Split dose preparation |
| Split dose preparation; PM colonoscopy | Experimental | Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon. Receives: Drug: Split dose preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Lactulose as a Preparation for Colonoscopy.
Efficacy assessed by the physician's determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue.
The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility.
Measured: at least 3 hours post last consumption
Secondary outcomes (9)
Incidence of Treatment Failure
A treatment failure is defined in the protocol as a bowel preparation that receives a cumulative Boston Bowel Preparation Score less than 5, or has one or more of the segments scored as a 0.
Measured: at least 3 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)
A paper questionnaire contained a horizontal line 100 mm long with the right end labeled "Best Possible Experience" and the left end labeled "Worst Possible Experience". The patients were asked to use a pen to place a mark on the line at the point that best described their overall tolerability for the bowel preparation.
Scores were determined by measuring the distance of the mark from the left end of the line. So, a lower number would indicate a poor experience and a high number would reflect a positive experience, with 100 being the maximum score and one that describes the best possible experience with the preparation.
Measured: 3 - 15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1
Tolerability assessed by a patient questionnaire - Likert response to "was regimen a tolerable bowel prep?" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree
Measured: 3-15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2
Tolerability assessed by a patient questionnaire - Likert response to "I did not experience too much discomfort during the bowel prep" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree
Measured: 3-15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3
Tolerability assessed by a patient questionnaire - Likert response to "The dosing instructions were easy to understand and follow" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree
Measured: 3 - 15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant
Survey response to question: "Would you be willing to repeat this preparation if a colonoscopy was felt to be medically necessary at some point in the future? The outcome measure is reporting the percentage of participants who replied "Yes" to this survey question.
Measured: 3 - 15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant
Survey response to question: "if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications.
Measured: 3 to 15 hours post last consumption
Colonic Hydrogen Gas Levels
Measured: 3 - 15 hours post last consumption
Colonic Methane Gas Levels
Measured: 3 - 15 hours post last consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colonoscopy PreparationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Krause, M.D, Principal investigator, ClinSearch, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887470
- Sponsor's protocol ID
- CPI-KR-004
- Status last verified
- May 2015
- First submitted
- 21 Jun 2013
- Last updated
- 1 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of 2 Regimens of Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
- ClinicalTrials.gov ID
- NCT01887470
- Acronym / sponsor ID
- CPI-KR-004
- Conditions
- Colonoscopy Preparation
- Keywords
- Bowel Evacuation, Colonoscopy Preparation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.
Detailed description
A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose regimen, where three doses are taken on the prior evening, and one dose is taken the morning of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full dose preparation; AM colonoscopy | Experimental | Drug: Full dose preparationFour hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day. |
| Full dose preparation; PM colonoscopy | Experimental | Drug: Full dose preparationFour hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day. |
| Split dose preparation; AM colonoscopy | Experimental | Drug: Split dose preparationThree hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon. |
| Split dose preparation; PM colonoscopy | Experimental | Drug: Split dose preparationThree hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring bowel evacuation for colonoscopy.
Key exclusion criteria (15 listed)
- Patients with galactosemia (galactose-sensitive diet).
- Patients known to be hypersensitive to any of the components of lactulose for oral solution.
- Patients with an abnormality on screening blood work or vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts.
- Patients with a history of impaired renal function.
- Patients with current or recent history of hypotension, as defined by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full dose preparationAlso: Evening-only Regimen | Drug | Full dose preparation; AM colonoscopy, Full dose preparation; PM colonoscopy |
| Split dose preparation | Drug | Split dose preparation; AM colonoscopy, Split dose preparation; PM colonoscopy |
Primary outcome
Efficacy of Lactulose as a Preparation for Colonoscopy.
Time frame: at least 3 hours post last consumption
Efficacy assessed by the physician's determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue. The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility.
9 secondary outcomes
Incidence of Treatment Failure
Time frame: at least 3 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)
Time frame: 3 - 15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1
Time frame: 3-15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2
Time frame: 3-15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3
Time frame: 3 - 15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant
Time frame: 3 - 15 hours post last consumption
Tolerability of and Preference for Lactulose as a Bowel Evacuant
Time frame: 3 to 15 hours post last consumption
Colonic Hydrogen Gas Levels
Time frame: 3 - 15 hours post last consumption
Colonic Methane Gas Levels
Time frame: 3 - 15 hours post last consumption
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Krause, M.D principal investigator
ClinSearch, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Full dose preparation and Split dose preparation in people with Colonoscopy Preparation, run by Cumberland Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Lactulose as a Preparation for Colonoscopy. (time frame: at least 3 hours post last consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.